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The handle http://hdl.handle.net/1887/38705 holds various files of this Leiden University dissertation.

Author: Gijn, Willem van

Title: Rectal cancer : developments in multidisciplinary treatment, quality control and European collaboration

Issue Date: 2016-02-18

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Improving quality of cancer care through surgical audit

W. van Gijn, C.J.H. van de Velde

On behalf of the members of the EURECCA consortium European Journal of Surgical Oncology 2010 Sep;36 Suppl 1:S23-6

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Quality of health care is a hot topic and this is especially true for cancer care.

New surgical techniques and effective neoadjuvant treatment regimens have significantly improved colorectal cancer outcome. Nevertheless, there seem to be substantial differences in quality of care between European countries, hospitals and doctors. To reduce hospital variation, most initiatives aim on selective referral, encouraging patients to seek care in high-volume hospitals, where cancer care is concentrated to site-specialist multidisciplinary teams. As an alternative to volume-based referral, hospitals and surgeons can also improve their results by learning from their own outcome statistics and those from colleagues treating a similar patient group. European national audit registries in surgical oncology have led to improvements with a greater impact on survival than any of the adjuvant therapies currently under study. Moreover, they offer the possibility to perform research on patient groups that are usually excluded from clinical trials.

Nevertheless, between European countries remain differences in outcome and treatment schedules that cannot be easily explained. The European CanCer Organisation (ECCO) has recognised these importance’s and created the ‘European Registration of Cancer Care’ (EURECCA) framework to develop a European colorectal audit structure. EURECCA will advance future treatment improvements and spread these to all European cancer patients. It provides opportunities to treat elderly and comorbid patients evidence based while it offers an unique insight in social-economical health care matters such as the consequences of commercialisation, treatment availability and screening initiatives. As such, ECCO has established the basis for a strong, multidisciplinary audit structure with the commitment to improve cancer care for every European cancer patient.

Summar y

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Introduction

Quality of health care is a hot topic and this is especially true for cancer care.

Several ranking lists for doctors and hospitals can be found on the internet and in the popular press around the world. Unfortunately, many of those lists do not meet the requirements needed for a fair judgement on health care providers and can therefore give misleading results. Nevertheless, the search for quality is plausible since there seem to be substantial diff erences in quality of care between countries, hospitals and doctors. In Europe, 5-year relative survival for colorectal cancer varies between 32% and 64%.1 In most western health care systems, eff orts are made to reduce hospital variation. Most initiatives focus on selective referral, encouraging patients to seek care in high-volume hospitals, where cancer care is concentrated to site-specialist multidisciplinary teams. Such a strategy of treating a larger proportion of patients in specialised centres can evidently improve outcomes for complex surgical procedures, like esophagectomies and pancreatectomies.2 Elsewhere in this EJSO supplement, a relationship between hospital or surgical volume and patient outcomes is demonstrated for breast and colorectal cancer.

However, the expertise for diagnosis and treatment of common types of cancer should be preferably widespread and easily accessible for all patients. Besides, one must keep in mind that there will always be low volume providers that perform very well as there are high volume providers with unacceptable outcomes. As an alternative to volume-based referral, hospitals and surgeons can also improve their results by learning from their own outcome statistics and those from colleagues treating a similar patient group. Quality assurance in surgical oncology is relative new compared to other medical fi elds such as chemotherapy and radiotherapy.

For a long time, surgery was thought to have too much unexpected variation to be feasible for standardisation and quality control. However, the perception of surgery is steadily shifting from being a non-defi nable craftsmanship to a trans- parent and well defi ned skill. Training, specialisation, knowledge, teamwork and continuous quality improvement are considered mandatory for surgeons in the 21st century.3 Surgical audit is a quality instrument that collects detailed clinical data from diff erent health care providers, which can be adjusted for baseline risk and subsequently fed back to individual hospitals or surgeons. In this way, ‘best practices’ can be identifi ed, communicated and broadly adopted. After case-mix adjustments, a fair judgement can be made on the quality of cancer treatments.

Hospitals and surgeons can be faced with their own results compared to those of colleagues treating the same patient category. Another important advantage is the fact that audit registries include the entire patient population which makes it possible to perform research on patient groups that are usually excluded from clinical trials (e.g. elderly, high comorbidity).

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European surgical audits for colorectal cancer

In the last two decades, several surgical audits have been established in Europe.

Most audits were initially set up for rectal cancer, because of poor outcome together with a remarkable variation between hospitals and between individual surgeons.4 In that time, several European studies had shown that improvements in outcome were possible when rectal cancer surgery was refined with the total mesorectal excision (TME) technique.5-7 Implementation of this new surgical technique and reduction of the variation in outcome between hospitals and surgeons were the main reasons to initiate audit registries for the surgical treatment of rectal cancer.

Later, most rectal cancer audits were broadened with colon cancer. Between 1993 and 2009, eight surgical (colo)rectal audits were founded in Europe (Table 1).

In 1993 the Norwegian Rectal Cancer Project was founded, including more than 99% of patients operated for rectal cancer. After four years the results of this audit were remarkable: the proportion of TME surgery rose from 78% to 92% and the local recurrence rate dropped from 28% to 7%.8 Moreover, the audit showed to be very cost effective with every saved life being less then €700.9 Currently, the audit’s name is changed to The Norwegian Colorectal Cancer Project because colon cancer is also being registered.

Table 1

European colorectal audit registations

  Audit Since

Norway Norwegian ColoRectal Cancer Project 1993 Denmark Danish Colorectal Cancer Database 1994 Sweden Swedish ColoRectal Cancer Registry 1995 UK National Bowel Cancer Audit Program 1999 Germany

Poland Italy

International Quality Assurance in

Colorecal Carcinoma 2000

Belgium Project on Cancer of the Rectum 2005

Spain Spanish TME project 2006

Netherlands Dutch Surgical Colorectal Audit 2009

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Th e Swedish Rectal Cancer Registry was set up in 1995 and includes over 97% of all Swedish rectal cancer patients.10 Postoperative mortality dropped under 2.5%

and the local recurrence rate dropped under 10%. Survival improved dramatically:

patients with rectal cancer had an even better 5-year survival rate than those with colon cancer.11 Th is is remarkable because in the same period important improvements in chemotherapy for patients with colonic cancer had been achieved.

Rectal cancer patients did not benefi t from these changes as adjuvant treatment after rectal cancer surgery is still considered experimental in many European countries. Th e fact that survival of rectal cancer patients was superior to those of colon cancer patients shows the considerable impact of structural surgical training and feedback. Nowadays, colon cancer is also part of the audit, which is renamed to Th e Swedish Colorectal Cancer Registry.

Th e Danish Colorectal Cancer Database also led to satisfying results. Since 1994, 93% of all colorectal cancer patients were included. After 5 years of auditing, 5-year survival increased from 42% to 63% for women and from 37% to 55% for men.12 More recently, other European countries followed in the Scandinavian footsteps by setting up their own national (colo)rectal audit programs. In 2001, Th e Association of Coloproctology of Great Britain and Ireland (ACPGBI) started the National Bowel Cancer Audit Programme (NBOCAP). In 2008, 95% of trusts in England and Wales submitted data. Within 5 years, 30 day mortality dropped from 7% to 4.5%.13 In 2000, the ‘International Quality Assurance in Colorectal Carcinoma’ was initiated in Magdeburg, Germany. Between 2000 and 2008, 372 hospitals from Germany and Poland included 57.429 patients. Since 2009, patients from Naples, Italy are included and Lithuania is scheduled to join 2010. Th e percentage of abdominoperineal excision was signifi cantly reduced from 26.1% in 2000 to 21.3%

in 2008.14

In 2005, Belgian surgeons initiated the Project on Cancer of the Rectum (PRO- CARE).15 After standardisation and implementation of guidelines, prospective regis tration started in 2006 on a voluntary basis. Until now, 50% of the Belgian hospitals participate and around 2500 patients are included.16 Besides registering crude outcome data after rectal cancer treatment, extensive eff orts and resources are used to train surgeons, pathologists and radiologists in the latest standards of rec tal cancer treatment.

In 2006 Spanish TME project was founded. Th is rectal cancer audit registration has a national coverage of 20%. So far, 3100 patients are included. First reports show a 30 day mortality of 3.1% and an anastomotic leakage rate of 8.2%.17

In 2009, the Dutch society of surgical oncology, the Dutch society of gastrointestinal surgery and the Dutch colorectal cancer group started the Dutch Surgical Colorectal Audit (DSCA). Within a year all hospitals in the Netherlands agreed to take part in the audit and more than 10,000 patients were included in early 2010. Recently, the DSCA published its fi rst annual report covering 2009.18 Obviously, in a fi rst report no statements can be made about the quality enhancing eff ect of the audit.

However, important fi ndings were discovered such as the percentage non-elective

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colon cancer operations. 21% of all operations were acute or urgent, with a mortality rate up to 14%. Striking is the fact that 26% of the patients that underwent acute or urgent surgery, had visited a surgical outpatient clinic before their situation became urgent. Given the fact that for colon cancer, mortality after elective surgery is only 2.9% compared to 14.3% after acute surgery, it seems obvious that many lives can be saved when these ‘unnecessary acute’ patients are reduced.

Considering the magnitude of improvements induced by the audit projects described above, the costs are futile in comparison to several adjuvant therapies.

Most importantly, the benefit for individual patients of most adjuvant therapies is several orders of magnitude smaller than that of the major improvements achieved by the audits.

European Registration of Cancer Care [EURECCA]:

an international, multi disci plinary, outcome-based quality improvement project of the European CanCer Organisation

Although all national audits achieved excellent results, differences remain between European countries that cannot be easily explained. On review of the results, there are differences in mortality, complications, recurrence and survival. Moreover, there are substantial differences in (neo) adjuvant treatment regimens. While in Sweden and The Netherlands most rectal cancer patients receive preoperative radiotherapy, in Norway a minority of patients receive radiotherapy (4% between 1993 and 1997).9 Nevertheless, local recurrence rates in Norway equal the rates in Sweden and The Netherlands.8

Despite the numerous national projects, international initiatives are limited. To generate the best care for colorectal cancer in the whole of Europe and to meet political and public demands for transparency, a deep and broad insight in treatment outcomes is needed union wide. A European audit registration will provide transparency, benchmarking and feedback across nation’s borders. This can rapidly lead to treatment improvements and a decrease in variation in the quality of care around the continent.

Urged by these arguments, the European CanCer Organisation (ECCO) initiated an international, multidisciplinary, outcome-based quality improvement program:

European Registration of Cancer Care (EURECCA). The goal is to create a multidisciplinary European registration structure for patient, tumour and treatment characteristics linked to outcome registration (morbidity, mortality, locoregional control, and survival). The registration will be used for benchmarking and internal feedback among participants and consequently enhance further improvements in quality and efficiency of cancer care. All eight audit registries

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partners in realizing the vision are the European CanCer Organisation, the European Society of Surgical Oncology, the European Society for Th erapeutic Radiology and Oncologists, the European Organisation of Research and Treatment of Cancer and the national audit structures.

Th e EURECCA project has a strong clinical research component complemented by the provision of practical tools for care providers all aiming at the optimization of the delivery of surgery, radiotherapy and chemotherapy in colorectal cancer. Among the main scopes of the research is the defi nition of the ‘core quality treatment standards’ which, by way of recommendations, will be systematically disseminated in order to optimise current treatment patterns and off er patients the maximum quality treatment locally available with strategies to limit undesirable eff ects. Th e main objectives of the project are:

n To perform research on the currently available population-based registries of patients with colorectal cancer in order to identify communalities and diff erences of surgery, radiotherapy and chemotherapy modalities of treatment in the European regions covered by these registries.

n Research to derive treatment outcomes from population-based registries in order to optimise current treatment approaches by defi ning ‘core quality treatment strategies’ as well as treatment recommendations.

n To integrate ‘core treatment quality strategies’ in clinical practice data collection, develop validation methods and facilitate outcome monitoring with feedback.

n To optimise the level of knowledge and experience in the treatment of colorectal cancer through professional education and dissemination programs.

Conclusion and future perspectives

National audit registries in surgical oncology have led to improvements with a greater impact on survival than any of the adjuvant therapies currently under study.

Moreover, they off er the possibility to perform research on patient groups that are usually excluded from clinical trials such as elderly. Th e ECCO has recognised these importances’s and created the EURECCA framework to develop a European colorectal audit structure. EURECCA will advance future treatment improvements and spread these to every cancer patient in Europe. It provides opportunities to treat elderly and comorbid patients evidence based while it off ers an unique insight in social- economical health care matters such as the consequences of commercialisation, treatment availability and screening initiatives. Although EURECCA defi nitely contributes to transparency in health care, there is emphatically no intention to create an environment which is dominated by a ‘naming, shaming and blaming culture’. Th erefore, individual surgeon or hospital data will only be accessible for the concerning health care providers, compared with an international case-mix adjusted mean outcome. While to a large extent, the EURECCA framework is still under construction, fi rst orientations are already made for future intercontinental comparisons.

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Momentarily, final preparations are made for pooled analyses on the effects of neoadjuvant radiotherapy on long term outcomes. Simultaneously, datasets are being harmonised to facilitate future analyses with respect to national privacy legislations. Early summarily results will be presented at the ESSO conference

‘surgical outcome: can we do better’ in September 2010 in Bordeaux. At this conference, a pre-negotiated call of agreement will be signed by all participants.

In 2011, a multidisciplinary consensus meeting will be organised in Perugia, Italy.

The objective is to present extensive results at the 2013 ECCO-17 conference in Amsterdam. As such, ECCO has established the basis for a strong, multidisciplinary audit structure with the commitment to improve cancer care for every European cancer patient.

All information about EURECCA can be found on the webpage: www.canceraudit.eu.

References

1. Sant M, Allemani C, Santaquilani M, et al. EUROCARE-4. Survival of cancer patients diagnosed in 1995e1999. Results and commentary. Eur J Cancer 2009;45(6):931-91.

2. Birkmeyer JD, Finlayson EV, Birkmeyer CM. Volume standards for high-risk surgical procedures: potential benefits of the leapfrog initiative. Surgery 2001;130(3):415-22.

3. McCulloch P. Surgical professionalism in the 21st century. Lancet 2006;367(9505):177-81.

4. Gatta G, Faivre J, Capocaccia R, et al. Survival of colorectal cancer patients in Europe during the period 1978e1989. Eur J Cancer 1998;34(14):2176-83.

5. Heald RJ, Husband EM, Ryall RD. The mesorectum in rectal cancer surgery e the clue to pelvic recurrence? Br J Surg 1982;69(10): 613-6.

6. Heald RJ, Ryall RD. Recurrence and survival after total mesorectal excision for rectal cancer. Lancet 1986;1(8496):1479-82.

7. MacFarlane JK, Ryall RD, Heald RJ. Mesorectal excision for rectal cancer. Lancet 1993;341(8843):457-60.

8. Wibe A, Moller B, Norstein J, et al. A national strategic change in treatment policy for rectal cancer e implementation of total mesorectal excision as routine treatment in Norway. A national Audit. Dis Colon Rectum 2002;45(7):857-66.

9. Wibe A. Nationwide quality Assurance of rectal cancer treatment. In: Colorectal con- gress. 28th November 2007, St. Gallen, Switzerland; 2007.

10. Påhlman L, Bohe M, Cedermark B, et al. The Swedish Rectal Cancer Registry. Br J Surg 2007;94(10):1285-92.

11. Birgisson H, Talback M, Gunnarsson U, et al. Improved survival in cancer of the colon and rectum in Sweden. Eur J Surg Oncol 2005;31(8):845-53.

12. Harling H, Bulow S, Kronborg O, et al. Survival of rectal cancer patients in Denmark during 1994-99. Colorectal Dis 2004;6(3):153-7.

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16. PROCARE: Global Results 2009; http://www.coldfusionwebhostings.be/PSK/upload/

File/Global_Results.pdf.

17. Spanish TME Project 2006-2008; http://www.aecirujanos.es/secciones/coloproctolo- gia/proyecto_vikingo_informe_2006-2008.pdf.

18. Dutch Surgical Colorectal Audit: Report 2009; http://www.dsca.nl/images/document- en/jaarrapportage%20DSCA.pdf.

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